Far Eastern Memorial Hospital
New Taipei City, Taiwan
NCT Number: NCT04458779
Stroke affects 16.9 million individuals each year and is the second leading cause of death worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of hospitalization for stroke remain high. These data emphasize the importance of identifying all treatable conditions that could aggravate stroke. One such condition is obstructive sleep apnea (OSA).
Sleep-related breathing disorders, including obstructive and central sleep apnea, often coexist with stroke. Compared to the general population, in whom OSA is the most common form of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes, accelerated neurological recovery.Apart from the benefits in better neurological outcomes, secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control studies to prove CPAP treatment would reduce the recurrence of cardiovascular or cerebrovascular events.
Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA. Notably, all of these studies above are observational or retrospective in nature. To date, there are no prospective longitudinal randomized controlled trials reporting the effect of CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized , controlled trial involving patients with stroke to test the primary hypothesis that treatment of OSA with CPAP would reduce the size of LA.
Looking for future studies?
Notify Me20 year–80 year
All sexes
Interventional
Not applicable
New Taipei City, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
Time frame: 12 months
Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.
Time frame: 12 months
Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
Time frame: 12 months
Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.
Time frame: 12 months
Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
Time frame: 12 months
Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
Time frame: 12 months
Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.
Time frame: 12 months
Numbers of cardiovascular or cerebrovascular events post randomization
Time frame: 12 months
Time to cardiovascular or cerebrovascular events post randomization
Time frame: 12 months
Numbers of hospitalizations for any reason post randomization
Time frame: 12 months
Numbers of deaths from all causes post randomization
Time frame: 12 months
Time to deaths from all causes post randomization
Far Eastern Memorial Hospital
Other
Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea
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